Actively Recruiting
Understanding Changes in the Gut Microbiome in Patients With Gallstone Disease and Its Impact on Patient Outcomes
Led by East Kent Hospitals University NHS Foundation Trust · Updated on 2024-02-23
75
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are exploring how the gut microbiome affects people with gallstone disease. This observational study aims to find out whether changes in the gut microbiome relate to complications like pancreatitis and acute cholecystitis, and how the microbiome shifts after gallbladder removal (cholecystectomy). The study focuses on adults diagnosed with gallstone disease and seeks to understand these relationships to improve patient outcomes. Participants will provide stool samples at specific times: at diagnosis, before surgery if needed, shortly after surgery, and then at 6 months and 3 years following cholecystectomy. Additional stool samples will be collected if participants are hospitalized with complications from gallstone disease. They will also complete 3-day food diaries to help researchers analyze the gut microbiome. During the study, researchers will collect medical data from patient records, including clinical history, diagnostic tests, blood results, and imaging done as part of routine care. Stool samples will be mailed to the research team for analysis of bacterial DNA profiles over up to 3 years. The study monitors how microbiome changes relate to complications before and after surgery, with the goal of identifying factors that affect patient health and treatment outcomes.
CONDITIONS
Brief Title
Influence of Gut Microbiome in Gallstone Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults over 18 years diagnosed with gallstone disease confirmed by imaging
- Patients of any gender, ethnicity, or socio-economic background
- Pregnant women are eligible
- Patients undergoing both open and laparoscopic gallbladder removal included
You will not qualify if you...
- Patients under 18 years of age
- Patients unable to provide consent for the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 3 years from diagnosis until cholecystectomy
Participants provide stool samples and clinical data at diagnosis and during follow-up before surgery.
Samples collected at diagnosis and every 6 months while awaiting surgery; a pre-operative sample within 6 weeks before surgery
Duration - Up to 1 week post-surgery
Participants undergo gallbladder removal and provide stool samples immediately after surgery to monitor post-operative changes.
1 visit during the first week after surgery
Duration - 6 months after surgery
Participants provide stool samples and clinical data 6 months after surgery to assess intermediate outcomes and complications.
1 visit at 6 months post-surgery
Duration - Up to 3 years from cholecystectomy
Participants are monitored through stool sample analysis and clinical data collection for up to 3 years following surgery to understand long-term outcomes.
Ongoing sample collection and clinical data monitoring during routine care
Trial Site Locations
Total: 1 location
1
EKHUFT
Ashford, Kent, United Kingdom, TN24 0LZ
Actively Recruiting
Research Team
C
Charlotte Burford
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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